FDA Video: New Pediatric Dosing Recommendations for Valcyte

FDA is notifying healthcare professionals about updated pediatric dosing recommendations for Valcyte oral tablets and solution. Valcyte is an antiviral medication used to prevent cytomegalovirus (CMV) disease in pediatric patients who have undergone kidney or heart transplants. The dosing change was made to prevent potential overdosing in children with low body weight, low body surface area, or below-normal serum creatinine.

Here are some of FDA's recommendations to help prevent overdoses:

• Follow the updated pediatric dosing algorithm in the Valcyte label.

• If the calculated pediatric dose of Valcyte exceeds 900 mg, give the child a dose of only 900 mg.

• And advise patients to contact their healthcare provider immediately if they experience signs and symptoms of overdose, including abdominal pain, vomiting, diarrhea, and seizure.